A study of GSK3511294 (Depemokimab) in participants who were previously enrolled in 206713 or 213744; Open-Label Extension

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Glaxosmithkline Research & Development Limited

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

26 Jul 2021 → 19 May 2025

Decision date (initial)

2024-02-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Research & Development Limited

External identifiers

EU CT number

2023-505203-23-01

EudraCT number

2020-004334-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To describe the long-term safety profile of GSK3511294 100 mg (SC) every 26 weeks in participants with severe asthma with an eosinophilic phenotype on top of existing asthma therapy over a 12 month open label extension phase.

Secondary objectives 1

1. To evaluate the effects of long-term dosing of GSK3511294 100 mg (SC) every 26 weeks on a range of clinical markers of asthma control and additional efficacy assessments on top of existing asthma therapy over a 12 month open label extension phase

Conditions and MedDRA coding

Severe asthma with an eosinophilic phenotype

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002836-PIP01-20

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants: Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
2. Age: Adults and adolescents ≥12 years of age, at the time of signing the informed consent/assent. [For countries where local regulations or the regulatory status of study medication permits enrolment of adults only, participants recruited will be ≥18 years of age]. Note: German and UK Participants: In Germany and UK only adult participants (≥18 years) are to be included in this clinical trial.
3. Male or eligible female • Female Participants: • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4.1 of the protocol OR o For all woman of childbearing potential (WOCBP) continuation of highly effective contraceptive method ( with a failure rate of <1%, as described in Section 10.4.2 of the protocol) is required between the prior study and enrolment into this study without any interruptions and must continue during the study intervention period and for at least 30 weeks after the last dose of study intervention. • A WOCBP must have a negative highly sensitive urine pregnancy test at Visit 1 prior to receiving first dose. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.5. of the protocol •If highly effective contraceptive method was interrupted prior to enrolment into this study, the reason for interruption must be discussed with medical monitor and the following must be done: o Highly effective contraceptive method must be restarted and continued for at least 14 days prior to first dose • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Note: If the childbearing potential changes after start of the study (e.g., a premenarcheal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception. If reproductive status is questionable, additional evaluation should be considered
4. Informed Consent: Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion criteria 12

1. Health Status: Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
2. Malignancy: A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localised carcinoma of the skin that was resected for cure will not be excluded).
3. Participants who have other clinically significant medical conditions uncontrolled with SoC therapy not associated with Asthma, e.g., uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
4. Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
5. Liver chemistry test: Participants who meet the following based results of week 48 assessment from Study 206713 or Study 213744 or from a later result: a) Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) b) Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) c) Liver Disease: Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C) are acceptable if participant otherwise meets eligibility criteria.
6. Vasculitis: Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
7. ECG Assessment: QTcF ≥450 msec or QTcF ≥480 msec for participants with Bundle Branch Block in the 12-lead ECG machine read at Visit 1.
8. Smoking status: Current smokers
9. Hypersensitivity: Participants with allergy/intolerance to the excipients of GSK3511294 in Section 6.1, a monoclonal antibody, or biologic.
10. Pregnancy: Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation. Requirements for pregnancy testing are located in Section 8.2.5.
11. Permanent Discontinuation of study intervention in Previous Study: Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
12. Other investigational product/clinical study: • Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term“investigational” applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of adverse events (AEs)/serious adverse events (SAEs) over 52 weeks
2. Incidence of immunogenicity as measured by the presence of anti-drug antibody (ADA)/ neutralising antibody (Nab) to GSK3511294 over 52 weeks

Secondary endpoints 4

1. Annualized rate of Clinically significant exacerbations over 52 weeks
2. Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at discrete timepoints during the 52 week period
3. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52
4. Change from Baseline in prebronchodilator FEV1 at Week 26 and Week 52

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

G S K House, 980 Great West Road 980 Great West Road

City

Brentford

Postcode

TW8 9GS

Country

United Kingdom

Scientific contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 4

Locations

7 EU/EEA countries · 62 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 48 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications